Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection
NCT ID: NCT05100446
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2021-05-01
2022-12-31
Brief Summary
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In Portugal, research studies estimate that more than 80% of the adult population has already contacted with H. pylori.
H. pylori infection is associated with active chronic gastritis in every colonized patient, what may consequently lead to peptic ulcer disease, atrophic gastritis, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma.
For that reason, H. pylori infection is considered to be a disease, independently of the presence of gastrointestinal symptoms. Additionally, H. pylori has been classified as a confirmed carcinogen (class I) by the International Agency for Research, being responsible for carcinogenic pathways conducting to both gastric adenocarcinoma and lymphoma. This fact gains a particular relevance taking into account that gastric cancer is one of the most prevalent cancers worldwide. On other hand, more than 75% of the gastric cancers occur following H. pylori infection.
Thus, H. pylori eradication constitutes an essential Public Health measurement, being inclusively considered a cost-effective method to decrease the gastric cancer burden, by promoting pre-malignant lesions regression, such as atrophic gastritis, and by delaying the disease progression in case of intestinal metaplasia or dysplasia.
Maastricht V consensus is a document updated in 2016, including the major recommendations regarding H. pylori diagnosis, follow-up and treatment. It highlights the emergence of antibiotic resistances and how they must influence clinical practice, namely the choice of antibiotic regimens, as successful eradication has become less frequent with more prevalent antibiotic resistances. This is the case of clarithromycin and metronidazol, both currently recommended as first-line options by the Portuguese Society of Gastroenterology. In fact, a systematic review conducted in 2018, aiming to evaluate antibiotic resistances on the Portuguese population observed that clarithromycin, metronidazole and double resistance occurred in 42%, 25% and 20% of the individuals, respectively.
Nowadays, Maastricht V guidelines recommend quadruple regimens containing bismuth, such as Pylera (r), as the first-line option in areas with significant double resistance to metronidazole and clarithromycin. Another option currently being investigated is the double therapy with amoxicillin in high doses and proton pump inhibitor. This has become a particularly attractive alternative due to its efficacy, good tolerability and significantly low resistance (\<1%) among the European population.
The aim of this clinical trial is to compare both regimens - pylera (r) and high-dose amoxycillin - in H. pylori eradication, regarding their efficacy, tolerability and side effects, in order to asses viable therapeutic options in a population with progressively increasing resistances to alternative regimens currently recommended.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment with Pylera (r) + esomeprazole 40mg
Pylera
Eradication with Pylera, for 10 days.
Esomeprazole 40mg
Esomeprazole 40mg, twice a day.
Treatment with high-dose amoxicillin + esomeprazole 40mg
Amoxicillin - high dose dual therapy
Eradication with Amoxicillin 1000mg + 500 mg + 1000mg + 500mg, for 15 days.
Esomeprazole 40mg
Esomeprazole 40mg, twice a day.
Interventions
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Amoxicillin - high dose dual therapy
Eradication with Amoxicillin 1000mg + 500 mg + 1000mg + 500mg, for 15 days.
Pylera
Eradication with Pylera, for 10 days.
Esomeprazole 40mg
Esomeprazole 40mg, twice a day.
Eligibility Criteria
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Inclusion Criteria
* Age equal or greater to 18 years
* Recent (\<6months) upper digestive endoscopy
* Ability to consent to participate in the study
Exclusion Criteria
* Contraindications to any of the available drugs
* Antibiotics use for the last 4 weeks
* Previous gastric cancer
* Previous gastric surgery
* Pregnancy
* Breastfeeding
18 Years
75 Years
ALL
Yes
Sponsors
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Unidade Local de Saúde do Alto Ave, EPE
OTHER
Responsible Party
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Vitor Bruno Macedo da Silva
Medical Doctor
Locations
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Vítor Bruno Macedo da Silva
Guimarães, , Portugal
Countries
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Facility Contacts
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Vítor Bruno Macedo Silva, M.D.
Role: primary
Other Identifiers
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101/2020
Identifier Type: -
Identifier Source: org_study_id